CA2401094C - Drug delivery device - Google Patents
Drug delivery device Download PDFInfo
- Publication number
- CA2401094C CA2401094C CA2401094A CA2401094A CA2401094C CA 2401094 C CA2401094 C CA 2401094C CA 2401094 A CA2401094 A CA 2401094A CA 2401094 A CA2401094 A CA 2401094A CA 2401094 C CA2401094 C CA 2401094C
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- CA
- Canada
- Prior art keywords
- dry
- injection device
- compartment
- automatic injection
- seal structure
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/343—Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/206—With automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
- A61M2005/287—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3145—Filters incorporated in syringes
Abstract
The present invention is directed to a drug delivery device. The device includes an interior chamber and a seal structure. In accordance with the present invention, the interior chamber may include a first, liquid medicament compartment and a second medicament compartment. The seal structure is conditionable to permit fluid to pass therethrough upon pressurization of the fluid. The seal structure preferably includes a sealing member which moves from a first sealed position into a second by-pass position upon pressurization of the liquid injection solution in the wet compartment of the housing assembly. Such by-pass movement of the sealing member enables the liquid injection solution to flow through the seal structure into the second ingredient compartment and mix for injection.
Description
DRL'G DELIVF.13..Y DEl7ICE
Eap OF ?HE TNVENTfON
The present invent.ion relaies io dntg delivery dzvices for delivering a me4icame.tlt. ln paructtlaF, The prescn-E invcmion is direczcd w aa autaasut.tic ivjector ass&anbly for quickly combining rwo components to forrn a liquid medicament, aud delivering the liquid medicament to an iujection site.
8ACI:GROUND OF ~~E INYEN~ON
~ .
An automatic injector is a device that enables intrarmuscular (IM) or subcutaneous administration of a dosage of inedicainem_ Generally, tbe medicament is stored as a licluicl farmulation which is Then injected intramoscularly. An advanuge of automatic injectors is ftt they contain a measured dosage of a liquid medicament in a sealed sterfle cartridge_ As such, automatic injectors allow for quick and simple iM
injection of a liquid medicament in emergency situstions without the need for measuring dosages. Aiaother advantage of automatic in,jeetors is that the administration of the medicament is accomplished without the user initially seeing the hylwdermic needle through which the medicantent is delivered, and'without requiting tbe user to ruauually force the needle into the patienz. This is paniculariy advantageous when the medscament is being self-administered.
There are drawbacks associated with the long--term storage of tuedieament in a liquid fortaulation. Fox instance, some medicatneuu are anot stable in solurion and thus have a shorter shelf life than their solid cournerparis. To address this concern, auiomatic injectors have been developed whirb store the medicament in solid form aad mix the solid medicametxt with a liquid solution immediately prior to injection. These injectors, disclosed for example in US Reissue Patem No. 35,986, entitled "Multip}e Chamber Automatic Injector,"
however, require t.he user of the injector to manually rupture I i a sealing member between the solid and liquid components and then manually shake the injector body to expedite, dissolution of the solid component prior to injection. This increases The time needed to administer a dose of The rnedicarnent. However, rapid delivery of the rnedscament is needed in many emergency medical situations (e.g., nerve gas and chzmical agent poisoning). Other wetldry injection devices have been expensive to manufaeiure or provided unsatisfactory mixing of components prior to injzction. Therefore, there is a need for a cost-effective automatic i.njector that stores medicament in solid form that does not require manual premixing by the user.
SUXMARYOF THk ItVVENTION
In response io the foregoing challenges, applicants have developed an innovative automatic injection device containing a pre-loaded charge of medicament for automatically administering the medicament upon actuation thereof. The auzomaiic injection device comprises a housing assembly and a chamber disposed within The housing assembly. The interior chamber includes a dry compattment for storing a predetermined charge of dry medicament therein, and a wet cornparunenz for storing a predetermined amount of liquid injection solution therein. A seal structure is disposed to seal the dry compartment from the wet compartment while the injection device is in storage. The seal suucture permits the liquid injection solution to pass therethrough and mix with the dry medicament to form a medieament mixture within the chamber during an injection operation. A needle assembly is in communication with the ruedicament mixture during the injection operation to enable administration of the medicament mixture. A plunger is disposed withia the chamber and is movable t}uough the chamber during the injection operation to force the medicament mixture through the needle for adrninistration of the medicament mixture. A scored energy activauon assembly is operable to release siored energy that forces The plunger through the chamber during the injection operation. The seal structure is conditionalable in responae to operation of the activation assembly to permit the liquid solution to pass therethrough and mix with the dry medicament as aforesaid.
Other aspects and advantages of the present invention will become apparent from the following detailed description, drawings and clairns_ BRIEF IlESCRlPTION OF THE DRAWINGs The invention will be described in conjunction with the following drawing in which like reference numerals designate like elements and wherein;
FIG. I is a longitudinal eross-sectional view of a wet/dry automatic injecior assembly in accordance with an embodiment of the present invention.
FIGs. 2A-2B illustrate lonsitudinal cross-sectional views of needle support assemblies in accordance with certain embodiments of the present invention.
FIGs. 3A-3D illustrate cross-sectional side views of various cartridge or chamber configurations and corresponding needle assembly options according to certain embodiments of the present invention.
FIG. 4 is an enlarged partial cross-sectional side view of a needle assernbly/cartridge engagement according to the embodiment illustrated in FIG.
3A.
FIGs. SA-5D illustrate cross-sectional side views of various embodiments of a seal structure according to the present invention.
I 5 FIG. 6A is a longitudinal cross-sectional side view of a seal structure in accordance with another embodiment of the present invention, wherein the movable sealing plug is in a closed sealing position blocking the flow of the liquid injection solution; and FIG. 6B is a longiiudinal cross sectional side view of seal structme similar to 6A, but showing the movable sealing plug in an open by-pass position permitting the flow of the liquid injection solution.
FIG. 6C is a lateral cross sectional view of the seal suucture of the present invention taken through the line 6C-6C in FIG. 6A.
FIG. 6D is a laieral cross sectional view of the seal structure of the present invention tai:en through the line 6T)-6I) in FIG. 6B.
FIG. 7 is a longitudinal cross-sectional view of a wet/dry automatic injector cazuidge or chamber configuration in accordance wit another embodiment of the present invention.
FlGs. 8A and SB are longitudinal cross sectional views of two additional embodiments of seal structures in accordance with the present inve.ntion.
DETAILED DF-SCRIPTION OF THE PREFERRED EMBODIMENT
Referring now, more particularlyto the figures, there is shown in FIG. 1 an automaiic injector assembly 10 in accordance with an embodiment of the present invention. The present invention is described in connection witlt a push button type auto injeccor, whereby the user rcmoves an end cap assembly and presses a button to trigger the injection process. The presant invention, however, is not litnited to push button type automatic injectors; rather, it iS contempIated ihat the present invention may be incorporated into a nose activated auto in,jector, as described for example in U_S _ Patent No. 5,3 54,2$6, The automatic injector assembly 10 includes a generally hollow tubular plastic housing 110. Generally, the housing ;10 includes an injection end 111 and an activazion end 112, as shown in FIG_ I. In the embodiment shown, an actuator assembly 120 is insened into the rearward end of the housing I 10. The actuator assembly 120 is received within the housing 1 10 unril flange I 15 of a sleeve member 144 snaps into annular groove 117 on the interior surface of housing 110. A
removable safety cap 130 is releasably secured to the actuator assembly 120.
The actuaior assembly 120 is of any conventional rype as known in the art, such as that disclosed in commonly assigned U.S. Patent No. 5,391,151 'I1le present invention employs a rear-end activatiztg device, similar to that in the aforementioned U.S. Patent No_ 5,391,151, and is therefore only briiefly discussed berein. The actuator assembly 120 includes an activation button sleeve 132 having internal activation surfaces 134. The activation assembly further includes a plastic collet 122 with a split rearward portion fonning spring fingers 136 as known in the an. The safety cap 130 has a pin portion 138 that extznds baween the spring fingers 136 so as io keep ihem spread apan when the injector is in a storage condition.
The spring fingers 136 terrninate in semi-conical configurations including rearwardly facing sloping surfaces 139 and forwardly facing flat surfaces 142. The collec 122 is surrounded by a cylindrical sleeve 144 having inwardly extending flange 146 at the rearward end thereof. The collet 122 has a I'Qrward annular flange 148. A coil spring 250 surrounds the collet 122 and is compressed betwee.n the flange 148 and flange 146, The collet flat surfaces 142 are retained in engagement with the rearwardly faCiri.g surfaces of the flange 146, and thus prevented from moving off of the flange surfaces by the pin 138 when The injector is stored.
To activate The injector, the safety pin 130 is manually pulled off of the rear end of the injector, thus removing pin 138 from between the fingers 136. The activation bunon 132 can then be pushed inwardly, and as a result of the activation surfaces thereof, 134 engages the sloping surfaces 139 of the spring fingers 136. This forces the spring fingers 136 inwards toward one another and off of the retaining surfaces of the flange 146. The compressed spring 250 is then free to release the stored energy therein to move the collet 122 forwardly under the force of the spring to affect an injection opcration as wiil be described later in more detail.
It is contemplated that the actuator assembly 120 can be of any type known in the automatic injector an that employs releasable stored energy. For example, rather than emptying a spring, it may employ a charge of compressed gas.
Located within the interior of The housing I 10 is a vial or chamber 150, preferably made of glass, for coniaining both the liquid injection solution and the dry medicament. The chamber 150 is preferably a hollow cylinder, with a smooth cylindrical inner surface. The liquid injection solution is Iocaied within a wet portion 1 S 2 of the chamber 150. The dry medicament is located within a dry portion 152 of the chamber 150. It is contemplated that the dry medicament may bc in powder, lyophilized, freeze-dried, or any other solid formulation known in The an. A
seal structure 160 engages the interior side walls of the chamber 150 to seal The dry portion 152 from the wet ponion 151 and to prevent seepage of the liquid injection solulion into the dry portion 152 prior to activation of the injector assembly.
Further, a needle assembly 140 mounts to the forward end of vial or chamber 150 to inject The medicament upon activaiion of the injector assembly. ln this embodiment, the forward end portion of the chamber 1 S0 has an annular groove 153 formed rherein for attachrnent of the needle assembly 140. The needle assembly 140 includes a funnel-shaped needle support 143. The wide end of the needle suppon 143 has an annular rib 145 that is snap-fit into groove 153 to form a seal with the chamber 150. The needle support 143 can be made of a resilient plastic material, or metal with a rubber seal that seats into groove 153. The forward narrow end 147 (see FIG. 2A) ofthe needle suppon 143 sealingly receives the rearward end of hollow needle 141. The needle support 143 forms a sealed fluid channel from the chamber 150 to the needle 141. A rubber needle sheath 202 surrounds the needle 141 and receives the narrow end 147 of the needle support 143. A flter 190 is sealingly retained across the entire wide-end mouth of the needle support 143 by an annular sealing washer 156.
F1Gs. 2B, 3A, and 4 illustrate another embodiment of a needle assembly 140 and charnber 150. The chamber 150 in this embodiment is known in the art as a dental cartridgr. The dzntal cartridge has a cylindrical rear portion and a nanowed forward neck portion defining an outer annular groove 153. The forward end of the dental cartridge defines an annular flanse portion 154. In this embodiment, the needle support 143 has a rearward annular flange 155 that reccives an annular sealing member 156 that surrounds both sides of flange 155. The sealing membcr 156 serves to scal a filtcr 190 over the wide end of the funnel shaped needle suppon 143. The rearward surface of the seaiing member 156 is sealingly clamped against the forward surface of chamber flange 154 by a metal retaining clamp 157 as best seen in FIG. 4.
Returning to FIG. 1, forward end 1221 ofthe collet 122 extends into the rearward end of chamber 150 and is adapted to connect with a plunger 170 rearwardly sealing the wet container 151. The plunger 170 is adapted to sealingly engage the side wall of the wet container 150 to preveni leakage of the contents (e.g., liquid injection aolution) of the wet container 3 51. The plunger 170 is preferably formed from a material having low frictional properties such that the collet 122 and plunger 170 may easily slide within the wet container 150 when operated. Alternauvely, the plunger 170 niay be lubricated with silicon or other suiiable non-reactive lubricant. The movement of the collet 122 and ihe plunger 170 pressuri2es thc liquid located within the wet container 151. A suitable medicament is located within a dry container 152.
'Ihe embodiment of F1Gs. I and 2A is advantageous in thai it has an open mouth configuration wherein the needle-end of the vial or chamber is not significantly narrowed or tapered. Such an open mouth configuration permits direct access to the dry ponion 152 of chamber 150 for easy loading. Further, the open mouth configuration aids in preventing cross contamination between wet portion 151 artd dry portion 152 in that the dry portion 152 does not have to be filled through liquid portion 151 of chamber 150. Needle assembly 140 can be mounted to vial or chal'uberr 150 in a snap-on configuration (F1G. 3B), an internal mount configuration (FIG. 3C), or an external needle assembly configurafion (FIG. 3D).
As mentioned above, the seal st.nicture 160 is adapted to engage the interior side walls of chamber 150 to prevent passage of the contents (e.g., liquid injection solution) of wet portion 151 into the dry portion 152 prior to activation of the automatic injection assembly. Generally, seal structure 160 can include an outer sealing member 180, a movable sealing plug 166, a by-pass zone 165, at least one flow path 167, and preferably also includes a filter or membrane 164. With reference to FIG. 5A-D, seal structure 160 can preferably be formed as a six piece (FIG. SA), five piece (FIG. SB), four pieee (F1G. 5C), or three piece (FIG. SD) configuration.
More particularly, with reference to FIG. 5A, the outer sealing struccuae 180 of the tiix picce configuraiion can comprisc a two piccc axmular rigid body I 81 whcrcin members 181 a, 181 b thereof are formed into the two piece rigid body using, e.g., annular weld connections or other bonding techniques known in the art. Outer sealing structure I SO can firrther include rnulciple extenlal sealing members 182, e.g., two 0-rings, to provide an annular sealing engagement with the inner wall of vial or compartment 150. The sealing stracture 180 further includes an internal plug member 166 and a filter or dispersion membrane 164 as will be discussed in greaier detail later.
In another zmbodiment, as shown in FIG. 5I3, rather than plural 0-rings, outer sealing structure 180 can include a single external sealing member 182, e.g., a uniiary gasket, to provide an annular sealing engagernent with the inner wall of vial or compartment 150. Fxternal sealing member 182 may optionally be secured to two piece rigid body 181 using any bonding techniques known in the art. Further, rigid body members 181 a, 181 b may be shaped such that they securingly engage external sealing members 182 within notched recesses 183. Alternately, sealing rnembers may be secured to rigid body members 181a,181b by an interference fit. As with the first embodiment, a filter or membrane 164 is clamped in place at the proximal end of flow path 167 beiween member 1 S 1 a and member 181 b of the two piece rigid body.
In another embodiment, as shown in FIG. 5C, outer sealing structure 180 comprises a unitary internal rigid member 181 and an external sealing member 182.
Again, internal rigid member 181 and external sealing member 182 may optionally be secured together using any bonding techniques known in the art. Furcher, internal rigid member 181 and eaternal sealing member 182 may be formed such that they securingly engage each other using a eombination of notched recesses 183 and extending shoulders 184. The filter or membrane 164 can be held in place between internal rigid member 181 and shoulder 184 of external sealing member 182. ln yet another embodiment, as shown in FIG. 5D, outer sealing object 180 can comprise a unitary external sealing member 182 which can optionally be molded so as to accomrnodate filter or member 164 within retaining recess 185. F1Gs. 6A and 6$ illust.rate another embAdiment that is very similar to that of F1G. 5A, but provides a slightly different shape for outer annular rigid body 181 and particularly the members 18ia,181b thereof.
ln each embodiment illustrated in FIGs. 5A-52:) and 6A-6B, external sealing member 182 is preferably formed from a non-reactive elastomer material which can provide for the necessary sealing engagement with the inner wall of vial or compartment 150. Further, external sealing member 182 can optionally be lubricated with silicon or other suitable non-reaction lubricant to facilitate movement of the outer sealing object 180 forwardly within vial or compartment ISO upon receiving sufficient force as will be described. The movable sealing plug 166 is preferably formed fram a material having low frictional propenies such that the sealing plug 166 may easily slide within ouier 'sealing object 180 when the injector is activated. 'i'he movable sealing plug 166 may also optionally be lubricated with silicon or other suitable non-reactive lubricant. In each of the embodiments illustrated, the outer annular structure defines an inner surface having a smooth cylindrical configuration towards the rearward porcion 169 thereof, and longitudinally extending grooves 168 towards the forward ponion thereof The grooves 168 create a flowpath or flowpaths 167 through which liquid in the wet compartment 151 can bypass seal plug 166 when the plug is moved forwardly from seaiing engagement with cylindrical surface portion 169 into the groovcd portion 168. The movement of the sealing plug 166 into the by-pass area 165 opens the fluid flow path 167 between wet poriion 151 and dry portion 152.
The movable scaling plug 166 preferably includes a plurality o#'circumfzrzntial grooves 186 io provide for enhanced sealing engagement and zo facilitate sliding action of the plug 166.
As mentioned above, the seal structure 160 preferably includes filter or membrane 164 at the end of flow path 167 through which the liquid injection solution may pass after the injector has been activated. The liquid injection solution then enters the dry portion 152 of the chamber 150 where it mixes with and dissolves the dry medicaxnent. More panicularly, the filter 164 disperses the liquid injection solution exiting the seal structure 160 to present laminar fluid flow to the full surface of the dry medicameni, thereby wetting the entire surface of the dry medicament for rapid and complete dissolution. The filtzr membrane 164 can be any structn-re that generally uniformly distributes the liquid across the entire diameter of the chamber 150 for enhanced dissolution of the dry medicament.
During operation, manual activation of the actuator assembly 120 releases the collet 122 (as described above), which applies pressure on the plunger assembly 170.
The application of pressure on the plunger assembly 170 by the collet and spring assembly 124 moves the plunger 170 in the direction of the needle assembly 140. As a result, the entire chamber 150 and needle assembly 140 are moved forwardly in the housing 110 such that needle 14] pierces through the front end of sheath 202 and exits through the forward end of the housing I 10, and particularly through a hole 204 in the front nose-cone portion 206 of The housing. The sheath 202, which serves to maintain the needle 141 sterile when the injector is in storage, also serves as a shock absorber during activation as it is compressed in generally accordion like fashion between the nose cone 206 and needle support 143.
When the needle 141 is extended from the housing 110 and the chamber 150 and needle support 143 approach the nose cone 206 portion of the housing so that ftzrcher forward movemeni of chamber 150 is substantially resisted, the plunger 170 then begins to travel forwardly rhrough the chamber 150. This pressuiizes the liquid injection solution located within the wet compartment 151. With reference to FIG. 6A-6B, The increased pressure within the wet compartment 15I moves The sealing plug 166 from a first sealed position wherein sealing plug, 166 is sealingly engaged with surface 169 of outer sealing structure 180 (FIG. 6A) to a second by-pass position (FIG. 6B) that allows The injection solution to flow tttrough flow path 167 created by grooves 168 and thereby through seal structure 160.
As described above, the high pressure developed within the wet portion 15l in response to movement of the colIet 122 and ihe plunger assembly 170 forces the liquid injection solution through the seal structure ] 60 dissolving the dru.g into a medieament injection solution which will then be forced out through the needle 141 and into the patieni. As the collet 122 and plunger assembly 170 continue forward, the plunger 170 will eventualiy coniaci The seal suucture 160, which, in a preferred embodiment, causes the seal struccure 160 to move in the direction of the needle assembly 140_ Movemeni of the seal struciure 160 would cause any remaining solution within thr pamon 152 to be dispersed through the needle assembly 140, so as to reduce The mouut of residual medicament remainiug within tbe ch=ber 150.
Referring to FIGS. 2A, 2B and 4, a medicament support 190, which may be a membrane or filter is preferably provided adjacent the needle assembly 140 to prevent any dry medicament particles from clogging the rearward end of needle 141 prior to an injection operation. The membrane 190 may also serve to slightly restrict or slow injection of medicament into the patient, to facilitate more thorough dissolution during injection.
More particularly, to prevent tbe paSsag+e of undissolved dry utedic=eut to the ncedle asscnnbly 140, a fnedicament supporc 190 is preferably provided betweeu the end of the dry comparqxient 152 and the needle assembly 140. The supporc 190 can serve to prevent blockage of the needle assembly 141 by preventing The dry medicamenr from entering The area =oundittg the needle assembly 140 while pernaitting passage of The mixure of dissolved merdicaxnent and liquid injeetion soiution.
It is contemplated that multiple s4spports 190 may be located within the dry comp4=ent 152. The provisiom of the supports 190 may also improve the Iaui.irtar flow of the liquid injection soltition through rhe dry medicamcnt thereby inoproving dissolution.
Fuwther, a d,iaphragm assembly (not shown) may also be provided adjacern the medicment support 190, as lcnowo in the arr. The diaphragm assembly acts to prevent the passage of the liquid injection solution to The needle assembly 140 prior to activation of the actuator assembly 120_ More particularly, The diaphragm assembly will nai r4pture until either The butt end of the needle assembly 140 naptutes the expanded diaphragm or sufficient pressure builds in the dry comparJment 160 to rupture the diaphmgoa, again as known in the an.
As discussed above, the movemeni of the collet 122 causes the iriection needle 141 of The inject.ion assembly 140 ro advauce and pTotrude through the housing 110.
As such, The injection of the medicarnenz can be performed with a simple operaTion_ In sum, the user simply removes the end cap assembly 130, locates the injerpon end of The housing 310 adjacent The injection site, and presses The push button 132. Thzs Qperation automatically trxggers the operation of the drive assembly or !~pring 250 to advance the collet 122 causins the liquid injection solution located within the wet portion 151 to enter the dry portion 152 through the seal structure 160. The dissolved medicament is then transmitted through the injection needle 141 io provide the user with the necessary dose of inedicament. The autornatic injector 10 in accordance with the present invention reduces the arnount of time required to administer rnedicament compared to other wet/dry injectors and eliminates the need for mixing by the user.
The seal structure 160 advantageously enables the manufacture of a superior wet/dry auto injector with a complementary combination of components that are either known in the an of conventional auto-injectors or are otherwise relaiively simple io manufaciuYe. The seal structure 160 ernables sufficient mixing of wet and dry medicament components without requiring manual shaking. This mixing action is enhanced by the filter or membrane 164. In a preferred embodiment, the ftlter 164 is a supported, hydrophobic acrylic copolymer casc on a non-woven nylon support.
Preferably, it is a FlouRepefIteated membrane for superior oleophobicity/hydro-phobiciry.
In olher embodiments (see FIGs. 8A and 8B), no inner plug 166 is provided.
Rather, the outer structure 180 is simply comple;rmented by a seal membrane 226 that extends across the inner area defined by the inner surface of the outer structtue. When the chamber 150 reaches the forward end of the housing during an injection operation, pressurization of the wet comparanent 151 causes the seal membrane 226 to rupture, thereby allowing the seal structure 160 to pernaii liquid io pass therethrough_ In this embodiment, it may be desirable to provide the seal structure 160 with a pointed member 228 disposed adjacent to the seal membrane 226 to facilitate rupnui.ng of the seal membrane upaTi pressurized expansion thereof during an injection operation_ The member 232 on which ihe pointed member 228 is mounted has a plura.lity of passages 234 that permits fluid to pass therethrough. Filter or membrane 164 is preferably moumed distal to the passages 234 to present laminar or distributed tlow to the dry medicameni.
EXAMPLES
An injector according io the present invention was loaded with liquid injeetion solution and dry medicameni and activated with the follow results.
*Trademark Loaded Dispensed C~perational Time Dry Powder Fluid Dry Powder Fluid mg Zvl1 % sng ml Secs_ 531 2.7 94 497 2.3 4.0 557 23 93 515 2.3 4.5.
592 2_6 92 537 22 4,4 it will be apparent to those skilled in the art ihat various modifications and variations may be made wiihouX departin,g from the scope of the present invention. For example, it is contemplated that a cover assembly, described for example iA
U.S. Patent No. 5,295,965 may be secured to the injection end of the housing 110 after deployment of the inedicam,ent. Furthermore, ihe automatic injector may further include a nipple pjunger assernbly, as described for exarnple in U_S. Paten.t No. 5,465,727., In yet a further embodiment, the forward dry chamber 152 contains The needle 141, as shown in FIG. 7. The needle 141 is forced through a forward plug stopper upon initial compression of the two chamber system. As known in the art, providing the needle in the forward chamber provides improved longitudinal compactness of the design.
in yet another embodiment, a pre-fiiled syrange is provided with The seal srxucture disposed between wet and dry compolienis.
In further contemplaied embodiments, The sea.l srructure 160 can be used in the same type of injector described herein, rxcept rather zia.an employing a dry (powder) rnedicament separated by a liquid component, a first liquid xnedicamerit is separated from a second fluid component by The seal structure 160. ln yet another embodiment, the seal structure 160 can be used in wh$t is known in the art as a "needleless injector"
where an injection can be made into a pazient without a needle or cannula.
T'hus, it is intended that rhe preSent invention covers the modifications and variations of the inveniion, provided they come within the scope of the appended claims aud their equivalencs.
Eap OF ?HE TNVENTfON
The present invent.ion relaies io dntg delivery dzvices for delivering a me4icame.tlt. ln paructtlaF, The prescn-E invcmion is direczcd w aa autaasut.tic ivjector ass&anbly for quickly combining rwo components to forrn a liquid medicament, aud delivering the liquid medicament to an iujection site.
8ACI:GROUND OF ~~E INYEN~ON
~ .
An automatic injector is a device that enables intrarmuscular (IM) or subcutaneous administration of a dosage of inedicainem_ Generally, tbe medicament is stored as a licluicl farmulation which is Then injected intramoscularly. An advanuge of automatic injectors is ftt they contain a measured dosage of a liquid medicament in a sealed sterfle cartridge_ As such, automatic injectors allow for quick and simple iM
injection of a liquid medicament in emergency situstions without the need for measuring dosages. Aiaother advantage of automatic in,jeetors is that the administration of the medicament is accomplished without the user initially seeing the hylwdermic needle through which the medicantent is delivered, and'without requiting tbe user to ruauually force the needle into the patienz. This is paniculariy advantageous when the medscament is being self-administered.
There are drawbacks associated with the long--term storage of tuedieament in a liquid fortaulation. Fox instance, some medicatneuu are anot stable in solurion and thus have a shorter shelf life than their solid cournerparis. To address this concern, auiomatic injectors have been developed whirb store the medicament in solid form aad mix the solid medicametxt with a liquid solution immediately prior to injection. These injectors, disclosed for example in US Reissue Patem No. 35,986, entitled "Multip}e Chamber Automatic Injector,"
however, require t.he user of the injector to manually rupture I i a sealing member between the solid and liquid components and then manually shake the injector body to expedite, dissolution of the solid component prior to injection. This increases The time needed to administer a dose of The rnedicarnent. However, rapid delivery of the rnedscament is needed in many emergency medical situations (e.g., nerve gas and chzmical agent poisoning). Other wetldry injection devices have been expensive to manufaeiure or provided unsatisfactory mixing of components prior to injzction. Therefore, there is a need for a cost-effective automatic i.njector that stores medicament in solid form that does not require manual premixing by the user.
SUXMARYOF THk ItVVENTION
In response io the foregoing challenges, applicants have developed an innovative automatic injection device containing a pre-loaded charge of medicament for automatically administering the medicament upon actuation thereof. The auzomaiic injection device comprises a housing assembly and a chamber disposed within The housing assembly. The interior chamber includes a dry compattment for storing a predetermined charge of dry medicament therein, and a wet cornparunenz for storing a predetermined amount of liquid injection solution therein. A seal structure is disposed to seal the dry compartment from the wet compartment while the injection device is in storage. The seal suucture permits the liquid injection solution to pass therethrough and mix with the dry medicament to form a medieament mixture within the chamber during an injection operation. A needle assembly is in communication with the ruedicament mixture during the injection operation to enable administration of the medicament mixture. A plunger is disposed withia the chamber and is movable t}uough the chamber during the injection operation to force the medicament mixture through the needle for adrninistration of the medicament mixture. A scored energy activauon assembly is operable to release siored energy that forces The plunger through the chamber during the injection operation. The seal structure is conditionalable in responae to operation of the activation assembly to permit the liquid solution to pass therethrough and mix with the dry medicament as aforesaid.
Other aspects and advantages of the present invention will become apparent from the following detailed description, drawings and clairns_ BRIEF IlESCRlPTION OF THE DRAWINGs The invention will be described in conjunction with the following drawing in which like reference numerals designate like elements and wherein;
FIG. I is a longitudinal eross-sectional view of a wet/dry automatic injecior assembly in accordance with an embodiment of the present invention.
FIGs. 2A-2B illustrate lonsitudinal cross-sectional views of needle support assemblies in accordance with certain embodiments of the present invention.
FIGs. 3A-3D illustrate cross-sectional side views of various cartridge or chamber configurations and corresponding needle assembly options according to certain embodiments of the present invention.
FIG. 4 is an enlarged partial cross-sectional side view of a needle assernbly/cartridge engagement according to the embodiment illustrated in FIG.
3A.
FIGs. SA-5D illustrate cross-sectional side views of various embodiments of a seal structure according to the present invention.
I 5 FIG. 6A is a longitudinal cross-sectional side view of a seal structure in accordance with another embodiment of the present invention, wherein the movable sealing plug is in a closed sealing position blocking the flow of the liquid injection solution; and FIG. 6B is a longiiudinal cross sectional side view of seal structme similar to 6A, but showing the movable sealing plug in an open by-pass position permitting the flow of the liquid injection solution.
FIG. 6C is a lateral cross sectional view of the seal suucture of the present invention taken through the line 6C-6C in FIG. 6A.
FIG. 6D is a laieral cross sectional view of the seal structure of the present invention tai:en through the line 6T)-6I) in FIG. 6B.
FIG. 7 is a longitudinal cross-sectional view of a wet/dry automatic injector cazuidge or chamber configuration in accordance wit another embodiment of the present invention.
FlGs. 8A and SB are longitudinal cross sectional views of two additional embodiments of seal structures in accordance with the present inve.ntion.
DETAILED DF-SCRIPTION OF THE PREFERRED EMBODIMENT
Referring now, more particularlyto the figures, there is shown in FIG. 1 an automaiic injector assembly 10 in accordance with an embodiment of the present invention. The present invention is described in connection witlt a push button type auto injeccor, whereby the user rcmoves an end cap assembly and presses a button to trigger the injection process. The presant invention, however, is not litnited to push button type automatic injectors; rather, it iS contempIated ihat the present invention may be incorporated into a nose activated auto in,jector, as described for example in U_S _ Patent No. 5,3 54,2$6, The automatic injector assembly 10 includes a generally hollow tubular plastic housing 110. Generally, the housing ;10 includes an injection end 111 and an activazion end 112, as shown in FIG_ I. In the embodiment shown, an actuator assembly 120 is insened into the rearward end of the housing I 10. The actuator assembly 120 is received within the housing 1 10 unril flange I 15 of a sleeve member 144 snaps into annular groove 117 on the interior surface of housing 110. A
removable safety cap 130 is releasably secured to the actuator assembly 120.
The actuaior assembly 120 is of any conventional rype as known in the art, such as that disclosed in commonly assigned U.S. Patent No. 5,391,151 'I1le present invention employs a rear-end activatiztg device, similar to that in the aforementioned U.S. Patent No_ 5,391,151, and is therefore only briiefly discussed berein. The actuator assembly 120 includes an activation button sleeve 132 having internal activation surfaces 134. The activation assembly further includes a plastic collet 122 with a split rearward portion fonning spring fingers 136 as known in the an. The safety cap 130 has a pin portion 138 that extznds baween the spring fingers 136 so as io keep ihem spread apan when the injector is in a storage condition.
The spring fingers 136 terrninate in semi-conical configurations including rearwardly facing sloping surfaces 139 and forwardly facing flat surfaces 142. The collec 122 is surrounded by a cylindrical sleeve 144 having inwardly extending flange 146 at the rearward end thereof. The collet 122 has a I'Qrward annular flange 148. A coil spring 250 surrounds the collet 122 and is compressed betwee.n the flange 148 and flange 146, The collet flat surfaces 142 are retained in engagement with the rearwardly faCiri.g surfaces of the flange 146, and thus prevented from moving off of the flange surfaces by the pin 138 when The injector is stored.
To activate The injector, the safety pin 130 is manually pulled off of the rear end of the injector, thus removing pin 138 from between the fingers 136. The activation bunon 132 can then be pushed inwardly, and as a result of the activation surfaces thereof, 134 engages the sloping surfaces 139 of the spring fingers 136. This forces the spring fingers 136 inwards toward one another and off of the retaining surfaces of the flange 146. The compressed spring 250 is then free to release the stored energy therein to move the collet 122 forwardly under the force of the spring to affect an injection opcration as wiil be described later in more detail.
It is contemplated that the actuator assembly 120 can be of any type known in the automatic injector an that employs releasable stored energy. For example, rather than emptying a spring, it may employ a charge of compressed gas.
Located within the interior of The housing I 10 is a vial or chamber 150, preferably made of glass, for coniaining both the liquid injection solution and the dry medicament. The chamber 150 is preferably a hollow cylinder, with a smooth cylindrical inner surface. The liquid injection solution is Iocaied within a wet portion 1 S 2 of the chamber 150. The dry medicament is located within a dry portion 152 of the chamber 150. It is contemplated that the dry medicament may bc in powder, lyophilized, freeze-dried, or any other solid formulation known in The an. A
seal structure 160 engages the interior side walls of the chamber 150 to seal The dry portion 152 from the wet ponion 151 and to prevent seepage of the liquid injection solulion into the dry portion 152 prior to activation of the injector assembly.
Further, a needle assembly 140 mounts to the forward end of vial or chamber 150 to inject The medicament upon activaiion of the injector assembly. ln this embodiment, the forward end portion of the chamber 1 S0 has an annular groove 153 formed rherein for attachrnent of the needle assembly 140. The needle assembly 140 includes a funnel-shaped needle support 143. The wide end of the needle suppon 143 has an annular rib 145 that is snap-fit into groove 153 to form a seal with the chamber 150. The needle support 143 can be made of a resilient plastic material, or metal with a rubber seal that seats into groove 153. The forward narrow end 147 (see FIG. 2A) ofthe needle suppon 143 sealingly receives the rearward end of hollow needle 141. The needle support 143 forms a sealed fluid channel from the chamber 150 to the needle 141. A rubber needle sheath 202 surrounds the needle 141 and receives the narrow end 147 of the needle support 143. A flter 190 is sealingly retained across the entire wide-end mouth of the needle support 143 by an annular sealing washer 156.
F1Gs. 2B, 3A, and 4 illustrate another embodiment of a needle assembly 140 and charnber 150. The chamber 150 in this embodiment is known in the art as a dental cartridgr. The dzntal cartridge has a cylindrical rear portion and a nanowed forward neck portion defining an outer annular groove 153. The forward end of the dental cartridge defines an annular flanse portion 154. In this embodiment, the needle support 143 has a rearward annular flange 155 that reccives an annular sealing member 156 that surrounds both sides of flange 155. The sealing membcr 156 serves to scal a filtcr 190 over the wide end of the funnel shaped needle suppon 143. The rearward surface of the seaiing member 156 is sealingly clamped against the forward surface of chamber flange 154 by a metal retaining clamp 157 as best seen in FIG. 4.
Returning to FIG. 1, forward end 1221 ofthe collet 122 extends into the rearward end of chamber 150 and is adapted to connect with a plunger 170 rearwardly sealing the wet container 151. The plunger 170 is adapted to sealingly engage the side wall of the wet container 150 to preveni leakage of the contents (e.g., liquid injection aolution) of the wet container 3 51. The plunger 170 is preferably formed from a material having low frictional properties such that the collet 122 and plunger 170 may easily slide within the wet container 150 when operated. Alternauvely, the plunger 170 niay be lubricated with silicon or other suiiable non-reactive lubricant. The movement of the collet 122 and ihe plunger 170 pressuri2es thc liquid located within the wet container 151. A suitable medicament is located within a dry container 152.
'Ihe embodiment of F1Gs. I and 2A is advantageous in thai it has an open mouth configuration wherein the needle-end of the vial or chamber is not significantly narrowed or tapered. Such an open mouth configuration permits direct access to the dry ponion 152 of chamber 150 for easy loading. Further, the open mouth configuration aids in preventing cross contamination between wet portion 151 artd dry portion 152 in that the dry portion 152 does not have to be filled through liquid portion 151 of chamber 150. Needle assembly 140 can be mounted to vial or chal'uberr 150 in a snap-on configuration (F1G. 3B), an internal mount configuration (FIG. 3C), or an external needle assembly configurafion (FIG. 3D).
As mentioned above, the seal st.nicture 160 is adapted to engage the interior side walls of chamber 150 to prevent passage of the contents (e.g., liquid injection solution) of wet portion 151 into the dry portion 152 prior to activation of the automatic injection assembly. Generally, seal structure 160 can include an outer sealing member 180, a movable sealing plug 166, a by-pass zone 165, at least one flow path 167, and preferably also includes a filter or membrane 164. With reference to FIG. 5A-D, seal structure 160 can preferably be formed as a six piece (FIG. SA), five piece (FIG. SB), four pieee (F1G. 5C), or three piece (FIG. SD) configuration.
More particularly, with reference to FIG. 5A, the outer sealing struccuae 180 of the tiix picce configuraiion can comprisc a two piccc axmular rigid body I 81 whcrcin members 181 a, 181 b thereof are formed into the two piece rigid body using, e.g., annular weld connections or other bonding techniques known in the art. Outer sealing structure I SO can firrther include rnulciple extenlal sealing members 182, e.g., two 0-rings, to provide an annular sealing engagement with the inner wall of vial or compartment 150. The sealing stracture 180 further includes an internal plug member 166 and a filter or dispersion membrane 164 as will be discussed in greaier detail later.
In another zmbodiment, as shown in FIG. 5I3, rather than plural 0-rings, outer sealing structure 180 can include a single external sealing member 182, e.g., a uniiary gasket, to provide an annular sealing engagernent with the inner wall of vial or compartment 150. Fxternal sealing member 182 may optionally be secured to two piece rigid body 181 using any bonding techniques known in the art. Further, rigid body members 181 a, 181 b may be shaped such that they securingly engage external sealing members 182 within notched recesses 183. Alternately, sealing rnembers may be secured to rigid body members 181a,181b by an interference fit. As with the first embodiment, a filter or membrane 164 is clamped in place at the proximal end of flow path 167 beiween member 1 S 1 a and member 181 b of the two piece rigid body.
In another embodiment, as shown in FIG. 5C, outer sealing structure 180 comprises a unitary internal rigid member 181 and an external sealing member 182.
Again, internal rigid member 181 and external sealing member 182 may optionally be secured together using any bonding techniques known in the art. Furcher, internal rigid member 181 and eaternal sealing member 182 may be formed such that they securingly engage each other using a eombination of notched recesses 183 and extending shoulders 184. The filter or membrane 164 can be held in place between internal rigid member 181 and shoulder 184 of external sealing member 182. ln yet another embodiment, as shown in FIG. 5D, outer sealing object 180 can comprise a unitary external sealing member 182 which can optionally be molded so as to accomrnodate filter or member 164 within retaining recess 185. F1Gs. 6A and 6$ illust.rate another embAdiment that is very similar to that of F1G. 5A, but provides a slightly different shape for outer annular rigid body 181 and particularly the members 18ia,181b thereof.
ln each embodiment illustrated in FIGs. 5A-52:) and 6A-6B, external sealing member 182 is preferably formed from a non-reactive elastomer material which can provide for the necessary sealing engagement with the inner wall of vial or compartment 150. Further, external sealing member 182 can optionally be lubricated with silicon or other suitable non-reaction lubricant to facilitate movement of the outer sealing object 180 forwardly within vial or compartment ISO upon receiving sufficient force as will be described. The movable sealing plug 166 is preferably formed fram a material having low frictional propenies such that the sealing plug 166 may easily slide within ouier 'sealing object 180 when the injector is activated. 'i'he movable sealing plug 166 may also optionally be lubricated with silicon or other suitable non-reactive lubricant. In each of the embodiments illustrated, the outer annular structure defines an inner surface having a smooth cylindrical configuration towards the rearward porcion 169 thereof, and longitudinally extending grooves 168 towards the forward ponion thereof The grooves 168 create a flowpath or flowpaths 167 through which liquid in the wet compartment 151 can bypass seal plug 166 when the plug is moved forwardly from seaiing engagement with cylindrical surface portion 169 into the groovcd portion 168. The movement of the sealing plug 166 into the by-pass area 165 opens the fluid flow path 167 between wet poriion 151 and dry portion 152.
The movable scaling plug 166 preferably includes a plurality o#'circumfzrzntial grooves 186 io provide for enhanced sealing engagement and zo facilitate sliding action of the plug 166.
As mentioned above, the seal structure 160 preferably includes filter or membrane 164 at the end of flow path 167 through which the liquid injection solution may pass after the injector has been activated. The liquid injection solution then enters the dry portion 152 of the chamber 150 where it mixes with and dissolves the dry medicaxnent. More panicularly, the filter 164 disperses the liquid injection solution exiting the seal structure 160 to present laminar fluid flow to the full surface of the dry medicameni, thereby wetting the entire surface of the dry medicament for rapid and complete dissolution. The filtzr membrane 164 can be any structn-re that generally uniformly distributes the liquid across the entire diameter of the chamber 150 for enhanced dissolution of the dry medicament.
During operation, manual activation of the actuator assembly 120 releases the collet 122 (as described above), which applies pressure on the plunger assembly 170.
The application of pressure on the plunger assembly 170 by the collet and spring assembly 124 moves the plunger 170 in the direction of the needle assembly 140. As a result, the entire chamber 150 and needle assembly 140 are moved forwardly in the housing 110 such that needle 14] pierces through the front end of sheath 202 and exits through the forward end of the housing I 10, and particularly through a hole 204 in the front nose-cone portion 206 of The housing. The sheath 202, which serves to maintain the needle 141 sterile when the injector is in storage, also serves as a shock absorber during activation as it is compressed in generally accordion like fashion between the nose cone 206 and needle support 143.
When the needle 141 is extended from the housing 110 and the chamber 150 and needle support 143 approach the nose cone 206 portion of the housing so that ftzrcher forward movemeni of chamber 150 is substantially resisted, the plunger 170 then begins to travel forwardly rhrough the chamber 150. This pressuiizes the liquid injection solution located within the wet compartment 151. With reference to FIG. 6A-6B, The increased pressure within the wet compartment 15I moves The sealing plug 166 from a first sealed position wherein sealing plug, 166 is sealingly engaged with surface 169 of outer sealing structure 180 (FIG. 6A) to a second by-pass position (FIG. 6B) that allows The injection solution to flow tttrough flow path 167 created by grooves 168 and thereby through seal structure 160.
As described above, the high pressure developed within the wet portion 15l in response to movement of the colIet 122 and ihe plunger assembly 170 forces the liquid injection solution through the seal structure ] 60 dissolving the dru.g into a medieament injection solution which will then be forced out through the needle 141 and into the patieni. As the collet 122 and plunger assembly 170 continue forward, the plunger 170 will eventualiy coniaci The seal suucture 160, which, in a preferred embodiment, causes the seal struccure 160 to move in the direction of the needle assembly 140_ Movemeni of the seal struciure 160 would cause any remaining solution within thr pamon 152 to be dispersed through the needle assembly 140, so as to reduce The mouut of residual medicament remainiug within tbe ch=ber 150.
Referring to FIGS. 2A, 2B and 4, a medicament support 190, which may be a membrane or filter is preferably provided adjacent the needle assembly 140 to prevent any dry medicament particles from clogging the rearward end of needle 141 prior to an injection operation. The membrane 190 may also serve to slightly restrict or slow injection of medicament into the patient, to facilitate more thorough dissolution during injection.
More particularly, to prevent tbe paSsag+e of undissolved dry utedic=eut to the ncedle asscnnbly 140, a fnedicament supporc 190 is preferably provided betweeu the end of the dry comparqxient 152 and the needle assembly 140. The supporc 190 can serve to prevent blockage of the needle assembly 141 by preventing The dry medicamenr from entering The area =oundittg the needle assembly 140 while pernaitting passage of The mixure of dissolved merdicaxnent and liquid injeetion soiution.
It is contemplated that multiple s4spports 190 may be located within the dry comp4=ent 152. The provisiom of the supports 190 may also improve the Iaui.irtar flow of the liquid injection soltition through rhe dry medicamcnt thereby inoproving dissolution.
Fuwther, a d,iaphragm assembly (not shown) may also be provided adjacern the medicment support 190, as lcnowo in the arr. The diaphragm assembly acts to prevent the passage of the liquid injection solution to The needle assembly 140 prior to activation of the actuator assembly 120_ More particularly, The diaphragm assembly will nai r4pture until either The butt end of the needle assembly 140 naptutes the expanded diaphragm or sufficient pressure builds in the dry comparJment 160 to rupture the diaphmgoa, again as known in the an.
As discussed above, the movemeni of the collet 122 causes the iriection needle 141 of The inject.ion assembly 140 ro advauce and pTotrude through the housing 110.
As such, The injection of the medicarnenz can be performed with a simple operaTion_ In sum, the user simply removes the end cap assembly 130, locates the injerpon end of The housing 310 adjacent The injection site, and presses The push button 132. Thzs Qperation automatically trxggers the operation of the drive assembly or !~pring 250 to advance the collet 122 causins the liquid injection solution located within the wet portion 151 to enter the dry portion 152 through the seal structure 160. The dissolved medicament is then transmitted through the injection needle 141 io provide the user with the necessary dose of inedicament. The autornatic injector 10 in accordance with the present invention reduces the arnount of time required to administer rnedicament compared to other wet/dry injectors and eliminates the need for mixing by the user.
The seal structure 160 advantageously enables the manufacture of a superior wet/dry auto injector with a complementary combination of components that are either known in the an of conventional auto-injectors or are otherwise relaiively simple io manufaciuYe. The seal structure 160 ernables sufficient mixing of wet and dry medicament components without requiring manual shaking. This mixing action is enhanced by the filter or membrane 164. In a preferred embodiment, the ftlter 164 is a supported, hydrophobic acrylic copolymer casc on a non-woven nylon support.
Preferably, it is a FlouRepefIteated membrane for superior oleophobicity/hydro-phobiciry.
In olher embodiments (see FIGs. 8A and 8B), no inner plug 166 is provided.
Rather, the outer structure 180 is simply comple;rmented by a seal membrane 226 that extends across the inner area defined by the inner surface of the outer structtue. When the chamber 150 reaches the forward end of the housing during an injection operation, pressurization of the wet comparanent 151 causes the seal membrane 226 to rupture, thereby allowing the seal structure 160 to pernaii liquid io pass therethrough_ In this embodiment, it may be desirable to provide the seal structure 160 with a pointed member 228 disposed adjacent to the seal membrane 226 to facilitate rupnui.ng of the seal membrane upaTi pressurized expansion thereof during an injection operation_ The member 232 on which ihe pointed member 228 is mounted has a plura.lity of passages 234 that permits fluid to pass therethrough. Filter or membrane 164 is preferably moumed distal to the passages 234 to present laminar or distributed tlow to the dry medicameni.
EXAMPLES
An injector according io the present invention was loaded with liquid injeetion solution and dry medicameni and activated with the follow results.
*Trademark Loaded Dispensed C~perational Time Dry Powder Fluid Dry Powder Fluid mg Zvl1 % sng ml Secs_ 531 2.7 94 497 2.3 4.0 557 23 93 515 2.3 4.5.
592 2_6 92 537 22 4,4 it will be apparent to those skilled in the art ihat various modifications and variations may be made wiihouX departin,g from the scope of the present invention. For example, it is contemplated that a cover assembly, described for example iA
U.S. Patent No. 5,295,965 may be secured to the injection end of the housing 110 after deployment of the inedicam,ent. Furthermore, ihe automatic injector may further include a nipple pjunger assernbly, as described for exarnple in U_S. Paten.t No. 5,465,727., In yet a further embodiment, the forward dry chamber 152 contains The needle 141, as shown in FIG. 7. The needle 141 is forced through a forward plug stopper upon initial compression of the two chamber system. As known in the art, providing the needle in the forward chamber provides improved longitudinal compactness of the design.
in yet another embodiment, a pre-fiiled syrange is provided with The seal srxucture disposed between wet and dry compolienis.
In further contemplaied embodiments, The sea.l srructure 160 can be used in the same type of injector described herein, rxcept rather zia.an employing a dry (powder) rnedicament separated by a liquid component, a first liquid xnedicamerit is separated from a second fluid component by The seal structure 160. ln yet another embodiment, the seal structure 160 can be used in wh$t is known in the art as a "needleless injector"
where an injection can be made into a pazient without a needle or cannula.
T'hus, it is intended that rhe preSent invention covers the modifications and variations of the inveniion, provided they come within the scope of the appended claims aud their equivalencs.
Claims (30)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An automatic injection device containing a pre-loaded charge of medicament for automatically administering the medicament upon actuation thereof, the device comprising:
a housing assembly having an interior chamber, the interior chamber having a dry compartment and a wet compartment, the dry compartment containing a dry medicament component, and the wet compartment containing a liquid component to be mixed with the dry component;
a seal structure between the dry compartment and the wet compartment, the seal structure initially in a sealing condition that maintains the dry component sealed from the liquid component, the seal structure including at least one flow path formed therein, the seal structure converting to a mixing condition in response to activation of the device, the seal structure including an inner seal plug movable within the seal structure and having a plurality of longitudinal grooves around the periphery of the inner seal plug;
a fluid distributing member disposed between the wet compartment and the dry compartment that creates a laminar fluid flow as the liquid component passes through the seal structure from the wet compartment into the dry compartment;
a needle assembly that dispenses the charge of medicament from the housing assembly; and an activation assembly carried by the housing assembly and including a stored energy source, wherein activation of the activation assembly releases stored energy from the stored energy source to cause: a) the seal structure to convert from the sealing condition to the mixing condition to permit the liquid component to pass through the at least one flow path from the wet compartment to the dry compartment, b) the liquid component to be forced through the fluid distributing member and distributed to the dry component to facilitate mixing and dissolution of the dry medicament component in the liquid component, and c) the mixed liquid and dry components to be forced through the needle assembly.
a housing assembly having an interior chamber, the interior chamber having a dry compartment and a wet compartment, the dry compartment containing a dry medicament component, and the wet compartment containing a liquid component to be mixed with the dry component;
a seal structure between the dry compartment and the wet compartment, the seal structure initially in a sealing condition that maintains the dry component sealed from the liquid component, the seal structure including at least one flow path formed therein, the seal structure converting to a mixing condition in response to activation of the device, the seal structure including an inner seal plug movable within the seal structure and having a plurality of longitudinal grooves around the periphery of the inner seal plug;
a fluid distributing member disposed between the wet compartment and the dry compartment that creates a laminar fluid flow as the liquid component passes through the seal structure from the wet compartment into the dry compartment;
a needle assembly that dispenses the charge of medicament from the housing assembly; and an activation assembly carried by the housing assembly and including a stored energy source, wherein activation of the activation assembly releases stored energy from the stored energy source to cause: a) the seal structure to convert from the sealing condition to the mixing condition to permit the liquid component to pass through the at least one flow path from the wet compartment to the dry compartment, b) the liquid component to be forced through the fluid distributing member and distributed to the dry component to facilitate mixing and dissolution of the dry medicament component in the liquid component, and c) the mixed liquid and dry components to be forced through the needle assembly.
2. The automatic injection device according to claim 1, wherein the seal structure includes an outer seal member and the inner seal plug is movable with respect to the outer seal member from a sealing position that seals the wet compartment from the dry compartment to a mixing position that allows contents of the dry and wet compartments to mix.
3. The automatic injection device according to claim 2, wherein an inner side wall of the outer seal member includes the longitudinal grooves that enable flow of the liquid component around the inner seal plug and through the seal structure when the seal plug is moved to the mixing position.
4. The automatic injection device according to claim 2, wherein the outer seal member of the seal structure comprises an external sealing member and an internal rigid body configured so as to securingly engage each other.
5. The automatic injection device according to claim 4, wherein the internal rigid body is formed from two rigid members which are annularly welded or bonded together.
6. The automatic injection device according to claim 5, wherein the fluid distributing member is clamped between the two rigid members of the internal rigid body.
7. The automatic injection device according to claim 1, wherein the needle assembly comprises a membrane adjacent the dry compartment, the membrane preventing undissolved dry medicament from entering the needle assembly.
8. The automatic injection device according to claim 1, wherein:
the fluid distributing member includes a filter or membrane; and the needle assembly comprises a membrane adjacent the dry compartment to prevent undissolved dry medicament from entering the needle assembly.
the fluid distributing member includes a filter or membrane; and the needle assembly comprises a membrane adjacent the dry compartment to prevent undissolved dry medicament from entering the needle assembly.
9. The automatic injection device according to claim 1, wherein the fluid distributing member creates fluid flow in only the longitudinal direction of the automatic injection device.
10. The automatic injection device according to claim 1, wherein the fluid distributing member comprises a filter or membrane.
11. The automatic injection device according to claim 1, wherein the inner seal plug has a solid core and is movable in the longitudinal direction of the automatic injection device.
12. The automatic injection device according to claim 1, wherein the seal structure has an outer periphery that forms a peripheral seal with an interior wall of the interior chamber, and the inner seal plug is spaced radially inward from the peripheral seal.
13. The automatic injection device according to claim 1, wherein the activation assembly includes a pre-compressed spring.
14. The automatic injection device according to claim 1, wherein the seal structure and the distributing member are integrated into a single assembly.
15. The automatic injection device according to claim 1, wherein the needle assembly is disposed toward a forward end of the housing assembly and the activation assembly is disposed toward a rearward end of the housing assembly, and the dry compartment is disposed forwardly of the wet compartment.
16. The automatic injection device according to claim 15, wherein the activation assembly includes a pre-compressed spring that urges a collet rod forwardly through the housing assembly, the forward movement of the collet rod creating sufficient pressure on the liquid component to cause the liquid component to force the seal structure into the mixing condition.
17. The automatic injection device according to claim 16, wherein the seal structure is movable forwardly with respect to the housing assembly as the collet rod is moved forwardly.
18. The automatic injection device according to claim 1, further comprising a dry medicament support structure disposed between the dry medicament component and the needle assembly.
19. The automatic injection device according to claim 1, wherein the seal structure includes four longitudinal grooves symmetrically located around the periphery of the inner seal plug.
20. An automatic injection device containing a pre-loaded charge of medicament for automatically administering the medicament upon actuation thereof, the device comprising:
a housing assembly having an interior chamber, the interior chamber including a dry compartment and a wet compartment, the dry compartment containing a dry medicament component and the wet compartment containing a liquid component to be mixed with the dry component;
a seal structure between the dry compartment and the wet compartment, the seal structure initially in a sealing condition that seals the dry compartment from the wet compartment, the seal structure converting to a mixing condition in response to the activation of the injection device, the seal structure having a periphery that forms a peripheral seal slidably disposed with respect to an adjacent surface of the interior chamber, the seal structure having an inner seal plug spaced radially inward from the peripheral seal that seals at least one flow path formed in the seal structure prior to activation of the device, the inner seal plug movable from a sealing condition to a mixing condition to enable fluid to flow around the inner seal plug and through the at least one flow path from the wet compartment to the dry compartment;
a fluid distributing member disposed between the liquid component and the dry medicament component that creates a laminar fluid flow as the liquid component passes through the seal structure from the wet compartment into the dry compartment;
a needle assembly that dispenses the charge of medicament from the housing assembly; and an activation assembly carried by the housing assembly and including a stored energy source, wherein activation of the activation assembly releases stored energy from the stored energy source, and the release of the stored energy causes: a) the seal structure to be converted from the sealing condition to the mixing condition to permit the liquid component to pass through the at least one flow path and b) the mixed liquid and dry components to be forced though the needle assembly.
a housing assembly having an interior chamber, the interior chamber including a dry compartment and a wet compartment, the dry compartment containing a dry medicament component and the wet compartment containing a liquid component to be mixed with the dry component;
a seal structure between the dry compartment and the wet compartment, the seal structure initially in a sealing condition that seals the dry compartment from the wet compartment, the seal structure converting to a mixing condition in response to the activation of the injection device, the seal structure having a periphery that forms a peripheral seal slidably disposed with respect to an adjacent surface of the interior chamber, the seal structure having an inner seal plug spaced radially inward from the peripheral seal that seals at least one flow path formed in the seal structure prior to activation of the device, the inner seal plug movable from a sealing condition to a mixing condition to enable fluid to flow around the inner seal plug and through the at least one flow path from the wet compartment to the dry compartment;
a fluid distributing member disposed between the liquid component and the dry medicament component that creates a laminar fluid flow as the liquid component passes through the seal structure from the wet compartment into the dry compartment;
a needle assembly that dispenses the charge of medicament from the housing assembly; and an activation assembly carried by the housing assembly and including a stored energy source, wherein activation of the activation assembly releases stored energy from the stored energy source, and the release of the stored energy causes: a) the seal structure to be converted from the sealing condition to the mixing condition to permit the liquid component to pass through the at least one flow path and b) the mixed liquid and dry components to be forced though the needle assembly.
21. The automatic injection device according to claim 20, wherein the seal structure includes an outer seal member that forms the peripheral seal with respect to an adjacent surface of the interior chamber.
22. The automatic injection device according to claim 20, wherein the inner seal plug is movable in the longitudinal direction of the automatic injection device.
23. The automatic injection device according to claim 20, wherein the seal structure has a plurality of longitudinally extending grooves around the periphery of the inner seal plug that form the at least one flow path between the wet compartment and the dry compartment.
24. The automatic injection device according to claim 20, wherein the fluid distributing member comprises a filter or membrane.
25. The automatic injection device according to claim 20, wherein the fluid distributing member moves from an initial position spaced rearwardly from the needle assembly to a final position closer to the needle assembly relative to the initial position.
26. The automatic injection device according to claim 20, wherein the seal structure and the fluid distributing member are integrated into a single assembly.
27. The automatic injection device according to claim 20, wherein the seal structure moves from an initial position spaced rearwardly from the needle assembly to a final position closer to the needle assembly relative to the initial position.
28. The automatic injection device according to claim 20, wherein the activation assembly includes a pre-compressed spring.
29. The automatic injection device according to claim 20, wherein the needle assembly comprises a membrane adjacent the dry compartment, the membrane preventing undissolved dry medicament from entering the needle assembly.
30. A method of preparing a charge of medicament, comprising:
loading a dry medicament component into a dry compartment of an interior chamber of a housing assembly of an automatic injection device;
sealing the dry compartment from a wet compartment of the interior chamber with a seal structure, the seal structure having an outer seal member that forms a peripheral seal with an interior wall of the interior chamber, the seal structure also having a movable inner seal member that initially seals a flow path between the wet and dry compartments;
loading a liquid component into the wet compartment; and activating an activation assembly located in the housing assembly to release stored energy for:
pressurizing the liquid component in the wet compartment;
moving the movable inner seal member to open a fluid path between the wet and dry compartments;
forcing the liquid component around the inner seal member and through a fluid distributing member disposed between the wet and dry compartments to create a laminar fluid flow from the wet compartment to the dry compartment;
and mixing the liquid and dry components in the dry compartment to form the charge of medicament.
loading a dry medicament component into a dry compartment of an interior chamber of a housing assembly of an automatic injection device;
sealing the dry compartment from a wet compartment of the interior chamber with a seal structure, the seal structure having an outer seal member that forms a peripheral seal with an interior wall of the interior chamber, the seal structure also having a movable inner seal member that initially seals a flow path between the wet and dry compartments;
loading a liquid component into the wet compartment; and activating an activation assembly located in the housing assembly to release stored energy for:
pressurizing the liquid component in the wet compartment;
moving the movable inner seal member to open a fluid path between the wet and dry compartments;
forcing the liquid component around the inner seal member and through a fluid distributing member disposed between the wet and dry compartments to create a laminar fluid flow from the wet compartment to the dry compartment;
and mixing the liquid and dry components in the dry compartment to form the charge of medicament.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/897,422 US6641561B1 (en) | 2000-10-10 | 2001-07-03 | Drug delivery device |
| EP02256070.0A EP1393763B9 (en) | 2001-07-03 | 2002-09-02 | Drug delivery device |
| PCT/US2002/027949 WO2004022137A1 (en) | 2001-07-03 | 2002-09-03 | Drug delivery device |
| CA2401094A CA2401094C (en) | 2001-07-03 | 2002-09-03 | Drug delivery device |
| CY20161101204T CY1118409T1 (en) | 2001-07-03 | 2016-11-23 | MEDICINE DISTRIBUTION DEVICE |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/897,422 US6641561B1 (en) | 2000-10-10 | 2001-07-03 | Drug delivery device |
| EP02256070.0A EP1393763B9 (en) | 2001-07-03 | 2002-09-02 | Drug delivery device |
| PCT/US2002/027949 WO2004022137A1 (en) | 2001-07-03 | 2002-09-03 | Drug delivery device |
| CA2401094A CA2401094C (en) | 2001-07-03 | 2002-09-03 | Drug delivery device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2401094A1 CA2401094A1 (en) | 2004-03-03 |
| CA2401094C true CA2401094C (en) | 2010-03-16 |
Family
ID=32686115
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2401094A Expired - Lifetime CA2401094C (en) | 2000-10-10 | 2002-09-03 | Drug delivery device |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US6641561B1 (en) |
| EP (1) | EP1393763B9 (en) |
| CA (1) | CA2401094C (en) |
| CY (1) | CY1118409T1 (en) |
| WO (1) | WO2004022137A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP1393763B9 (en) | 2016-12-28 |
| EP1393763B1 (en) | 2016-08-24 |
| WO2004022137A1 (en) | 2004-03-18 |
| US6641561B1 (en) | 2003-11-04 |
| EP1393763A1 (en) | 2004-03-03 |
| CA2401094A1 (en) | 2004-03-03 |
| CY1118409T1 (en) | 2017-06-28 |
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| CA2401094C (en) | Drug delivery device | |
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